Point of Care

Human Infectious Diseases Rapid Tests

meningospeed ue

MeningoSpeed


The MeningoSpeed cassette test is a single use rapid immunoassay for the qualitative detection of Neisseria meningitidis serogroups A, C, W, Y, X in cerebrospinal fluid. 


This kit is intended for use as an aid in the diagnosis of N. meningitidis
MeningoSpeed cassettes

Performances

Human specimen
Cerebrospinal fluid (CSF)
Specimen volume
2 drops (40 – 60 μl)
Relative sensitivity
100% (versus culture)
95,6%   (versus PCR)
Relative specificity
100% (versus culture)
93,8%   (versus PCR)
Positive Predictive Value
100% (versus culture)
95,6%   (versus PCR)
Negative Predictive Value
100% (versus culture)
93,8%   (versus PCR)
Concordance
94,9% (kappa test at 0.89, p<0.05)
Assay time
3-10 minutes
The global correlation between results obtained with the MeningoSpeed test in comparison with bacterial culture, rapid test and agglutination test is of 100% on the CSF samples.
Only the PCR method is more sensitive when compared to MeningoSpeed, but it requires a qualified staff, technical handling and more time.

Protocol

The protocol described here is validated on both urine and CSF.

1. Read instructions carefully. Check expiration on individual test package; do not use any test past the expiration date on the label. Ensure each pouch is tightly sealed before use. Allow tests and samples to reach room temperature before use. Open the pouch only shortly before use (within 5 minutes).

2. Remove the cassette from the foil pouch by tearing at the notch and place it on a flat, horizontal surface.

3. Homogenize the sample. Holding the provided disposable pipet vertically, take a fraction of the sample and dispense one drop (30 µL) to the sample well “S” of the cassette. Add immediately 3 drops of diluent and start the timer. A purplish liquid will appear and move along the membrane.

4. Read result at fifteen (15) minutes. Some positive results may appear sooner. Results are not valid after 20 minutes.

5. Discard the test components and samples in accordance with your biohazard waste disposal protocol.

Result interpretation

To serve as a procedure control, a red colored line will appear at the control “CL” area, if the test has been performed properly. If no visible line appears in the CL area, repeat with a new test kit.

POSITIVE(S) TEST(S) – Distinct red bands appear in the control area (“CL”) and test area (“A, W, Y, C or X”) according to the identified serogroup of Neisseria meningitidis (Nm). The color intensity of the line may vary depending on the different level of infection.
In case of meningitis caused by Neisseria meningitidis Y, tests lines Y and W can appear due to an antigenic community. Observing these two purple lines indicates the presence of Neisseria meningitidis Y. In case of meningitis caused by Neisseria meningitidis W, only the W test line appears.

NEGATIVE(S) TEST(S) – Only one red line appears in the CT area on all three cassettes. No apparent lines appear in the test area (“A, W, Y, C or X”).

INVALID(S) TEST(S) – No visible line appears in the CT area, independently of the possible results of the test area (“A, W, Y, C or X”).

Video presentation

Ordering information

Name
MeningoSpeed
CE marking (April 2018)
Catalog reference
BSD-0200
Packing size
20 tests / kit
demo kit available (5 tests)
Price
upon request
Contact
This email address is being protected from spambots. You need JavaScript enabled to view it.
+33(0)7 82 51 57 83

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BioSpeedia
Institut Pasteur
25 rue du Docteur Roux
75015 PARIS
France

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Fax. 00 33 (0) 1 40 59 99 04
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